Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-VII: Sirolimus-eluting (Ultimaster) vs. Everolimus-Eluting Stents (Xience)

NCT ID: NCT03484234

Last Updated: 2019-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-27

Study Completion Date

2019-09-06

Brief Summary

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This study compares angiographic and clinical outcomes in patients with long coronary lesions treated with sirolimus-eluting stent (Ultimaster stent) or everolimus-eluting stent (Xience Alpine stent). The study uses a randomized, multicenter, controlled design approach.

Detailed Description

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Conditions

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Coronary Artery Disease Coronary Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultimaster stent

Group Type EXPERIMENTAL

Ultimaster stent

Intervention Type DEVICE

Percutaneous coronary intervention with Ultimaster stent for long lesion

Xience alpine stent

Group Type ACTIVE_COMPARATOR

Xience alpine stent

Intervention Type DEVICE

Percutaneous coronary intervention with Xience alpine stent for long lesion

Interventions

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Ultimaster stent

Percutaneous coronary intervention with Ultimaster stent for long lesion

Intervention Type DEVICE

Xience alpine stent

Percutaneous coronary intervention with Xience alpine stent for long lesion

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. The patient must be at least 19 years of age.
2. Significant native coronary artery stenosis (\>50% by visual estimate) with lesion length of more than 25mm, which requiring at long stent placement without intervening normal segment.
3. Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction (NSTEMI)
4. The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria

1. Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus
2. An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.
3. Acute ST-segment-elevation MI or cardiogenic shock
4. Terminal illness with life expectancy \<1 year
5. In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment). However, non-target vessel ISR is permitted.
6. Patients with EF\<30%.
7. Serum creatinine level ≥ 2.0mg/dL or dependence on dialysis.
8. Patients with left main stem stenosis (\>50% by visual estimate)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Seung-Jung Park

OTHER

Sponsor Role lead

Responsible Party

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Seung-Jung Park

Professor, Division of Cardiology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Gangwon National Univ. Hospital

Chuncheon, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AMCCV2018-05

Identifier Type: -

Identifier Source: org_study_id

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